FDA requires OxyContin pills to be non-crushable to deter abuse

The Food and Drug Administration announced Tuesday that it would block generic, crushable versions of OxyContin from coming to the market and approve the reformulated, non-crushable OxyContin, which deters abuse of the powerful painkiller.

U.S. Senate Republican Leader Mitch McConnell applauded the move. “Given the public health epidemic of prescription drug abuse and the ravaging effects it has on families all across Kentucky, this announcement is great news and will prevent an influx of crushable, generic OxyContin from coming to market,” McConnell said in a release.
 
OxyContin is a potent drug designed to treat severe pain. Without abuse-deterrent formulas, addicts can crush the pills to get an immediate heroin-like high. The reformulated product has properties that make the tablet harder to crush, break, or dissolve and that prevent it from being injected in order to achieve a quick high, an FDA press release said.

Drug overdoses are now the leading cause of death in Kentucky, and law enforcement, lawmakers and health providers have expressed their concerns that crushable, generic versions would worsen the problem.

The FDA decision came on the same day manufacturer Purdue Pharma’s patent on the original drug was set to expire, and McConnell has been actively meeting with federal officials on behalf of those concerned. Rep. Hal Rogers, R-5th, also lobbied for it. (Read more)

In an editorial, the Lexington Herald-Leader points out that the move means a continued OxyContin monopoly and more profits for Purdue Pharma, which "paid $600 million in fines in 2007, and three of the company's executives paid a total of $34.5 million, after they pleaded guilty to misleading doctors and the public about OxyContin's addictiveness. . . . We wonder why Rogers and McConnell aren't calling for Purdue to voluntarily share its new formulation."

The Food and Drug Administration announced Tuesday that it would block generic, crushable versions of OxyContin from coming to the market and approve the reformulated, non-crushable OxyContin, which deters abuse of the powerful painkiller.

U.S. Senate Republican Leader Mitch McConnell applauded the move. “Given the public health epidemic of prescription drug abuse and the ravaging effects it has on families all across Kentucky, this announcement is great news and will prevent an influx of crushable, generic OxyContin from coming to market,” McConnell said in a release.
 
OxyContin is a potent drug designed to treat severe pain. Without abuse-deterrent formulas, addicts can crush the pills to get an immediate heroin-like high. The reformulated product has properties that make the tablet harder to crush, break, or dissolve and that prevent it from being injected in order to achieve a quick high, an FDA press release said.

Drug overdoses are now the leading cause of death in Kentucky, and law enforcement, lawmakers and health providers have expressed their concerns that crushable, generic versions would worsen the problem.

The FDA decision came on the same day manufacturer Purdue Pharma’s patent on the original drug was set to expire, and McConnell has been actively meeting with federal officials on behalf of those concerned. Rep. Hal Rogers, R-5th, also lobbied for it. (Read more)

In an editorial, the Lexington Herald-Leader points out that the move means a continued OxyContin monopoly and more profits for Purdue Pharma, which "paid $600 million in fines in 2007, and three of the company's executives paid a total of $34.5 million, after they pleaded guilty to misleading doctors and the public about OxyContin's addictiveness. . . . We wonder why Rogers and McConnell aren't calling for Purdue to voluntarily share its new formulation."

Read More

FDA could require tamper-resistant painkillers; without such action, prescription-drug abuse problem would worsen

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

Read More

Kentucky to get $811,000 from drug company as settlement of federal suit alleging unfounded promotion of three medications

Attorney General Jack Conway has confirmed that the state will receive almost $811,000 for its share of recoveries in a settlement reached in a lawsuit filed by the federal government against Boehringer Ingelheim Pharmaceuticals Inc. In all, the drug company has agreed to pay $95 million to settle allegations that it promoted three drugs for uses in Kentucky and other states that were not medically accepted.  The Associated Press reports that the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent, and the high-blood-pressure drug Micardis are the drugs named in the suit. The Justice Department said the company also promoted the use of the heart drug Atrovent at doses exceeding those covered by federal health programs. (Read more)

Attorney General Jack Conway has confirmed that the state will receive almost $811,000 for its share of recoveries in a settlement reached in a lawsuit filed by the federal government against Boehringer Ingelheim Pharmaceuticals Inc. In all, the drug company has agreed to pay $95 million to settle allegations that it promoted three drugs for uses in Kentucky and other states that were not medically accepted.  The Associated Press reports that the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent, and the high-blood-pressure drug Micardis are the drugs named in the suit. The Justice Department said the company also promoted the use of the heart drug Atrovent at doses exceeding those covered by federal health programs. (Read more)

Read More

New tool allows analysis of nursing-home deficiencies across the country; Kentucky seems to rank high in serious problems

Reporters now have a tool at their fingertips that will allow them to find nursing home problems in facilities across Kentucky, which appears to ranks high in serious problems.(iStock photo)

The tool was launched this week by ProPublica, a nonprofit, investigative news group, and allows "anyone to easily search and analyze the details of recent nursing home inspections, most completed since January 2011," report Charles Ornstein and Lena Groeger.

The tool has features that the federal government's Nursing Home Compare doesn't have, including the ability to search using any keyword. Results can also be sorted according to the severity of the violation and by state.

About 1.5 million people still live in nursing homes nationwide, though more seniors are living at home or in assisted-living facilities. The reports show there were almost 118,000 deficiencies cited against 14,565 homes. According to the Centers for Medicare and Medicaid Services, the average number of deficiencies for a nursing home inspected in the U.S. is eight and the average in Kentucky is seven.

ProPublica's analysis shows Kentucky ranked fourth nationwide for the most "K" and "L" deficiencies, considered the most serious kind. The state had 45 in the analysis, as did South Carolina. Texas had the most in the country by far, however, with 183. 

While ProPublica does rank the states, nursing home industry officials say "inspectors in different regions of the country have different thresholds for issuing a citation, and that could unfairly make one state's homes appear worse than another's," Ornstein and Groeger report. (Read more)

Reporters now have a tool at their fingertips that will allow them to find nursing home problems in facilities across Kentucky, which appears to ranks high in serious problems.(iStock photo)

The tool was launched this week by ProPublica, a nonprofit, investigative news group, and allows "anyone to easily search and analyze the details of recent nursing home inspections, most completed since January 2011," report Charles Ornstein and Lena Groeger.

The tool has features that the federal government's Nursing Home Compare doesn't have, including the ability to search using any keyword. Results can also be sorted according to the severity of the violation and by state.

About 1.5 million people still live in nursing homes nationwide, though more seniors are living at home or in assisted-living facilities. The reports show there were almost 118,000 deficiencies cited against 14,565 homes. According to the Centers for Medicare and Medicaid Services, the average number of deficiencies for a nursing home inspected in the U.S. is eight and the average in Kentucky is seven.

ProPublica's analysis shows Kentucky ranked fourth nationwide for the most "K" and "L" deficiencies, considered the most serious kind. The state had 45 in the analysis, as did South Carolina. Texas had the most in the country by far, however, with 183. 

While ProPublica does rank the states, nursing home industry officials say "inspectors in different regions of the country have different thresholds for issuing a citation, and that could unfairly make one state's homes appear worse than another's," Ornstein and Groeger report. (Read more)

Read More